DAPA-CKD trial stopped early after ‘overwhelming benefit’ observed with dapagliflozin
The phase 3 DAPA-CKD trial assessing the benefit of the SGLT2 inhibitor dapagliflozin in adults with chronic kidney disease will be stopped early after investigators reported an “overwhelming benefit” for reduction in worsening renal function or renal death compared with placebo, according to a press release from AstraZeneca.
An independent data monitoring committee made the decision to stop the trial early after a routine assessment of efficacy and safety, which showed a benefit with dapagliflozin (Farxiga) earlier than originally anticipated. AstraZeneca will now initiate closure of the trial.
“Chronic kidney disease patients have limited treatment options, particularly those without type 2 diabetes,” Mene Pangalos, executive vice president, biopharmaceuticals research and development for AstraZaneca, said in the release. “We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world.”
The primary endpoint of DAPA-CKD is a composite of worsening of renal function or death, defined as a composite endpoint of at least 50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage renal disease, or cardiovascular or renal death in adults with CKD irrespective of the presence of type 2 diabetes.
In the release, AstraZeneca stated that the full study results will be submitted for presentation at a forthcoming medical meeting. The company plans to initiate discussions with global health authorities regarding early regulatory submissions.
As Healio previously reported, the FDA granted fast track designation in August for dapagliflozin for an indication to delay the progression of renal failure and prevent CV and renal death in adults with CKD. Dapagliflozin is under priority review with the FDA and under regulatory review at the European Medicines Agency for the treatment of adults with heart failure. – by Regina Schaffer
Disclosure: Pangalos is executive vice president, biopharmaceuticals research and development for AstraZaneca.